FDA Adverse Event Malfunction Summary report: N

2.5MM HEX SCREWDRIVER-LONG

MDR report key: 2954437 · Received February 11, 2013

Report

Report Number: 2520274-2013-00845
Event Type: Malfunction
Date Received: February 11, 2013
Date of Event: September 19, 2009
Report Date: September 22, 2009
Manufacturer: SYNTHES
Product Code: HXX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

Description of Event or Problem · 1

(B)(4) COMPLAINT HANDLING UNIT REPORTED THE SCREWDRIVER WAS BEING USED TO TIGHTEN GRUB SCREWS IN A LOW PROFILE TRANSCONNECTOR. THE TIP OF THE DRIVER BROKE OFF INTO THE TRANSCONNECTOR GRUB SCREW. THE FRAGMENT WAS SECURELY LODGED INTO THE GRAB SCREW AND WAS UNABLE TO REMOVE AND CONSEQUENTLY REMAINED IN THE PATIENT. THE SURGEON ACCEPTED THAT THIS FRAGMENT REMAINED IN THE PATIENT AND DID NOT MAKE A COMPLAINT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59929	2.5MM HEX SCREWDRIVER-LONG	2.5MM HEX SCREWDRIVER	HXX	SYNTHES

Patients

Seq	Age	Sex	Outcome	Treatment
1